Prospective Multicentric Randomized Trial Comparing the Efficacy and Safety of Sleeve Gastrectomy With Transit Bipartition (SG+TB) Versus Roux-en-Y Gastric Bypass (RYGB)
Overview
- Phase
- Not Applicable
- Intervention
- sleeve gastrectomy with transit bipartition (SG +TB)
- Conditions
- Severe Obesity
- Sponsor
- University Hospital, Lille
- Enrollment
- 320
- Locations
- 8
- Primary Endpoint
- The Excess Weight Loss percentage (EWL%)
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
Obesity is a major public health problem worldwide. Bariatric surgery has proved to be the most effective treatment of morbid obesity in terms of weight reduction and remission of co-morbid conditions during long-term follow-up. Sleeve Gastrectomy (SG) has become the most performed intervention either worldwide or in France, where SG represents more than 60% of bariatric interventions and 114,817 patients operated between 2013 and 2016.
Maximum Excess weight loss (%EWL) after SG is obtained at one-year post surgery. Then it has been largely reported in the literature that patients could present mild, moderate or important (notably in the super obese patients) weight regain associated with comorbidity relapse motivating redo surgery. Like in revisional surgery, operating super-obese patient (BMI ≥50 kg/m2) is a challenge. It has been shown that achieving significant weight loss was more difficult in patients with a BMI ≥ 50 compared to lower BMIs.
Detailed Description
In these 2 populations of patients, more malabsorptive procedures like long limb One Anastomosis Gastric Bypass or Bilio-Pancreatic Diversion with Duodenal Switch could be more efficient but induce technical difficulties (high complication rate) and can be responsible for malnutrition (vitamin deficiencies, hypoalbuminemia…). That's why, in case of revisional surgery or for high BMI patients,laparoscopic Roux-en-Y gastric bypass (RYGBP) is still considered as the gold standard and is the most performed intervention. To obtain better weight loss safely,Santoro et al. promoted the sleeve gastrectomy with transit bipartition (SG+TB), a new intervention coupling a SG without interrupting pathway through the duodenum and preserving the pylorus and a long biliary limb RYGBP. Hypothesis: Because there is no duodenal and jejunal exclusion, malnutrition is expected to be less frequent after SG+TB compared to BPD/DS. Its anastomosis on the antrum makes SG+TB easier to perform in super-obese patient than standard RYGB but more efficient in term of weight loss. Compared to BPD/DS or SADI which involves dissection of the duodenum and the confection of a duodenojejunostomy, SG+TB is also expected to be easier then safer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient who has benefited from a pluridisciplinary evaluation, with a favorable opinion for SG+TB or RYGB as a first intention procedure with BMI ≥40 kg/m2 or BMI ≥ 35 kg/m2 associated with one co-morbidity which will be improved by surgery (according to HAS 2009 recommendation3) OR as a second intention procedure (revisional surgery) after failure of Sleeve gastrectomy (defined as insufficient weight loss at 18 months after surgery (EWL% \<50), or as weight regain (+ 20%)).
- •Patient who had benefited from an Upper GI Endoscopy with biopsies to look for Helicobacter Pylori (HP) and a HP eradication.
- •Patient who understands and accepts the need for a long-term follow-up
- •Patient who agrees to be included in the study and who signs the informed consent form
- •Patient affiliated to a healthcare insurance plan
Exclusion Criteria
- •History of previous bariatric surgery, other than a Sleeve Gastrectomy
- •Patient with current BMI \> 60 kg/m2
- •Presence of a severe and evolutive life threatening pathology, unrelated to obesity
- •History of Chronic inflammatory bowel disease
- •Type 1 Diabetes
- •Pregnancy or desire to be pregnant during the study
- •Nursing woman
- •Presence of Pylori Helicobacter resistant to medical treatment
- •Presence of a non-healed gastro-duodenal ulcer or diagnosed less than 2 months previously
- •Severe esophagitis (grade C of Los Angeles classification)
Arms & Interventions
laparoscopic sleeve gastrectomy with transit bipartition (SG +TB)
One arm benefiting from a laparoscopic sleeve gastrectomy with transit bipartition (SG +TB)
Intervention: sleeve gastrectomy with transit bipartition (SG +TB)
laparoscopic Roux-en-Y gastric bypass (RYGB)
One arm benefiting from a laparoscopic Roux-en-Y gastric bypass (RYGB)
Intervention: Roux-en-Y gastric bypass (RYGB)
Outcomes
Primary Outcomes
The Excess Weight Loss percentage (EWL%)
Time Frame: at 2 years after surgery
The Excess Weight Loss percentage (EWL%) calculated with the following formula: ((weight at 2 years visit - initial weight (kg)) / (initial weight - ideal weight)) X 100 Ideal weight defined as the weight corresponding to a BMI = 25 kg/m2. Initial weight defined as preoperative weight at V1. All weights are expressed in kg
Secondary Outcomes
- Change nutritional status assessment(from baseline (before surgery) to 24 months after surgery)
- Change in liver status assessment(from baseline (before surgery) to 24 months after surgery)
- Change in vitamins status assessment(from baseline (before surgery) to 24 months after surgery)
- Evolution of muscle mass assessed by bioelectrical impedance analysis(from baseline to 24 months after surgery)
- Change in mineral status assessment(from baseline (before surgery) to 24 months after surgery)
- 24-hour steatorrhea quantified at 6 months(At 6 months)
- Complications rate within 2 years according to Dindo-Clavien classification(within 2 years)
- Length of hospital stay defined as the number of days of hospitalization(up to 2 week)
- Evolution of muscle mass assessed by grip strength test.(from baseline to 24 months after surgery)
- Change in Sigstad questionnaire score (dumping syndrome).(from baseline to 24 months after surgery)
- Change of food choices and preferences assessed by the Leeds Food Preference Questionnaire (LFPQ) score.(from baseline to 24 months after surgery)
- Evolution from baseline to 24 months after surgery of HbA1c level, HDL, LDL and triglycerides(from baseline to 24 months after surgery)
- Evolution from baseline to 24 months of insulinoresistance defined by HOMA-IR calculated with fasting blood glucose and fasting insulinemia12(from baseline to 24 months)
- Change of the GIQLI score(from baseline to 24 months after surgery)
- Change of the SF36 scores(from baseline to 24 months after surgery)
- Change of physical activity assessed by the International Physical Activity Index (IPAQ) score.(from baseline to 24 months after surgery)